Trial Outcomes & Findings for CTx-1301 Comparative Bioavailability Study (NCT NCT04138498)
NCT ID: NCT04138498
Last Updated: 2021-04-08
Results Overview
d-MPH Plasma concentration
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Hours 0 to 28
Results posted on
2021-04-08
Participant Flow
Subjects were recruited at a single site from November 22, 2019 to March 06, 2020.
Of 106 subjects who were screened, 45 (42.5%) were enrolled into the study and randomized to a sequence of treatment.
Participant milestones
| Measure |
Sequence 1 (ADBC)
Subjects in sequence ADBC received study treatments in the following order: Focalin XR 5 mg capsule, CTx-1301 50 mg tablet, CTx-1301 6.25 mg tablet, Focalin XR 40 mg capsule.
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
Dexmethylphenidate 6.25 mg Tablet: Experimental drug for comparative BA evaluation
Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
Dexmethylphenidate 50 mg Tablet: Experimental drug for comparative BA evaluation
|
Sequence 2 (BACD)
Subjects in sequence BACD received study treatments in the following order: CTx-1301 6.25 mg tablet, Focalin XR 5 mg capsule, Focalin XR 40 mg capsule, CTx-1301 50 mg tablet.
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
Dexmethylphenidate 6.25 mg Tablet: Experimental drug for comparative BA evaluation
Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
Dexmethylphenidate 50 mg Tablet: Experimental drug for comparative BA evaluation
|
Sequence 3 (CBDA)
Subjects in sequence CBDA received study treatments in the following order: Focalin XR 40 mg capsule, CTx-1301 6.25 mg tablet, CTx-1301 50 mg tablet, Focalin XR 5 mg capsule.
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
Dexmethylphenidate 6.25 mg Tablet: Experimental drug for comparative BA evaluation
Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
Dexmethylphenidate 50 mg Tablet: Experimental drug for comparative BA evaluation
|
Sequence 4 (DCAB)
Subjects in sequence DCAB received study treatments in the following order: CTx-1301 50 mg tablet, Focalin XR 40 mg capsule, Focalin XR 5 mg capsule, CTx-1301 6.25 mg tablet.
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
Dexmethylphenidate 6.25 mg Tablet: Experimental drug for comparative BA evaluation
Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
Dexmethylphenidate 50 mg Tablet: Experimental drug for comparative BA evaluation
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
12
|
12
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CTx-1301 Comparative Bioavailability Study
Baseline characteristics by cohort
| Measure |
Sequence 1 (ADBC)
n=11 Participants
Subjects in sequence ADBC will receive study treatments in the following order: Focalin XR 5 mg capsule, CTx-1301 50 mg tablet, CTx-1301 6.25 mg tablet, Focalin XR 40 mg capsule.
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
Dexmethylphenidate 6.25 mg Tablet: Experimental drug for comparative BA evaluation
Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
Dexmethylphenidate 50 mg Tablet: Experimental drug for comparative BA evaluation
|
Sequence 2 (BACD)
n=10 Participants
Subjects in sequence BACD will receive study treatments in the following order: CTx-1301 6.25 mg tablet, Focalin XR 5 mg capsule, Focalin XR 40 mg capsule, CTx-1301 50 mg tablet.
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
Dexmethylphenidate 6.25 mg Tablet: Experimental drug for comparative BA evaluation
Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
Dexmethylphenidate 50 mg Tablet: Experimental drug for comparative BA evaluation
|
Sequence 3 (CBDA)
n=12 Participants
Subjects in sequence CBDA will receive study treatments in the following order: Focalin XR 40 mg capsule, CTx-1301 6.25 mg tablet, CTx-1301 50 mg tablet, Focalin XR 5 mg capsule.
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
Dexmethylphenidate 6.25 mg Tablet: Experimental drug for comparative BA evaluation
Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
Dexmethylphenidate 50 mg Tablet: Experimental drug for comparative BA evaluation
|
Sequence 4 (DCAB)
n=12 Participants
Subjects in sequence DCAB will receive study treatments in the following order: CTx-1301 50 mg tablet, Focalin XR 40 mg capsule, Focalin XR 5 mg capsule, CTx-1301 6.25 mg tablet.
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
Dexmethylphenidate 6.25 mg Tablet: Experimental drug for comparative BA evaluation
Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
Dexmethylphenidate 50 mg Tablet: Experimental drug for comparative BA evaluation
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
45 participants
n=21 Participants
|
|
History of ADHD
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
45 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Hours 0 to 28Population: PK Completer Population
d-MPH Plasma concentration
Outcome measures
| Measure |
Treatment A
n=41 Participants
Focalin XR 5 mg capsule
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment B
n=39 Participants
CTx-1301 6.25 mg tablet
Dexmethylphenidate 6.25 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
Treatment B/A
n=39 Participants
PK Comparison of 6.25 mg CTx-1301 (treatment B) to 5 mg Focalin XR (treatment A)
|
Treatment C
n=43 Participants
Focalin XR 40 mg capsule
Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment D
n=42 Participants
CTx-1301 50 mg tablet
Dexmethylphenidate 50 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
Treatment D/C
n=42 Participants
PK Comparison of 50 mg CTx-1301 (treatment D) to 40 mg Focalin XR (treatment C).
|
|---|---|---|---|---|---|---|
|
Cmax
|
3138.41 pg/mL
Interval 2893.862 to 3403.633
|
2874.52 pg/mL
Interval 2646.813 to 3121.816
|
0.92 pg/mL
Interval 0.843 to 0.995
|
23884.13 pg/mL
Interval 22050.942 to 25869.722
|
24685.37 pg/mL
Interval 22774.231 to 26756.894
|
1.03 pg/mL
Interval 0.953 to 1.12
|
PRIMARY outcome
Timeframe: Hours 0 to 28Population: PK Completer Population
Area under the curve from time 0 extrapolated to infinite time
Outcome measures
| Measure |
Treatment A
n=41 Participants
Focalin XR 5 mg capsule
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment B
n=39 Participants
CTx-1301 6.25 mg tablet
Dexmethylphenidate 6.25 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
Treatment B/A
n=39 Participants
PK Comparison of 6.25 mg CTx-1301 (treatment B) to 5 mg Focalin XR (treatment A)
|
Treatment C
n=43 Participants
Focalin XR 40 mg capsule
Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment D
n=42 Participants
CTx-1301 50 mg tablet
Dexmethylphenidate 50 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
Treatment D/C
n=42 Participants
PK Comparison of 50 mg CTx-1301 (treatment D) to 40 mg Focalin XR (treatment C).
|
|---|---|---|---|---|---|---|
|
AUC(0-infinity)
|
24384.31 ng/mL
Interval 22579.167 to 26333.776
|
27661.46 ng/mL
Interval 25603.455 to 29884.885
|
1.13 ng/mL
Interval 1.09 to 1.181
|
203127.64 ng/mL
Interval 188123.507 to 219328.465
|
239317.53 ng/mL
Interval 221590.471 to 258462.729
|
1.18 ng/mL
Interval 1.133 to 1.225
|
PRIMARY outcome
Timeframe: Hours 0 to 28Population: PK Completer Population
AUC from time 0 to the last measurable concentration
Outcome measures
| Measure |
Treatment A
n=41 Participants
Focalin XR 5 mg capsule
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment B
n=39 Participants
CTx-1301 6.25 mg tablet
Dexmethylphenidate 6.25 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
Treatment B/A
n=39 Participants
PK Comparison of 6.25 mg CTx-1301 (treatment B) to 5 mg Focalin XR (treatment A)
|
Treatment C
n=43 Participants
Focalin XR 40 mg capsule
Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment D
n=42 Participants
CTx-1301 50 mg tablet
Dexmethylphenidate 50 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
Treatment D/C
n=42 Participants
PK Comparison of 50 mg CTx-1301 (treatment D) to 40 mg Focalin XR (treatment C).
|
|---|---|---|---|---|---|---|
|
AUC(Last)
|
22793.45 pg/mL
Interval 20666.366 to 25139.474
|
25540.99 pg/mL
Interval 23149.418 to 28179.632
|
1.12 pg/mL
Interval 1.075 to 1.169
|
190456.27 pg/mL
Interval 172736.598 to 209993.654
|
221949.48 pg/mL
Interval 201261.408 to 244764.129
|
1.17 pg/mL
Interval 1.118 to 1.214
|
SECONDARY outcome
Timeframe: Hours 0 to 28AUC from Hours 0-3, 3-6, 6-9, 9-12, and 12 to 16
Outcome measures
| Measure |
Treatment A
n=41 Participants
Focalin XR 5 mg capsule
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment B
n=39 Participants
CTx-1301 6.25 mg tablet
Dexmethylphenidate 6.25 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
Treatment B/A
n=39 Participants
PK Comparison of 6.25 mg CTx-1301 (treatment B) to 5 mg Focalin XR (treatment A)
|
Treatment C
n=43 Participants
Focalin XR 40 mg capsule
Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment D
n=42 Participants
CTx-1301 50 mg tablet
Dexmethylphenidate 50 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
Treatment D/C
n=42 Participants
PK Comparison of 50 mg CTx-1301 (treatment D) to 40 mg Focalin XR (treatment C).
|
|---|---|---|---|---|---|---|
|
Partial AUCs
AUC0-3
|
4928.24 hr*pg/mL
Interval 4520.066 to 5373.276
|
3943.21 hr*pg/mL
Interval 3612.595 to 4304.075
|
.80 hr*pg/mL
Interval 0.743 to 0.861
|
37963.37 hr*pg/mL
Interval 34854.01 to 41350.112
|
32744.35 hr*pg/mL
Interval 30044.791 to 35686.47
|
.86 hr*pg/mL
Interval 0.803 to 0.927
|
|
Partial AUCs
AUC3-6
|
6939.76 hr*pg/mL
Interval 6357.221 to 7575.675
|
6317.47 hr*pg/mL
Interval 5778.203 to 6907.071
|
0.91 hr*pg/mL
Interval 0.831 to 0.997
|
51204.34 hr*pg/mL
Interval 46939.593 to 55856.559
|
51368.60 hr*pg/mL
Interval 47085.223 to 56041.632
|
1.00 hr*pg/mL
Interval 0.918 to 1.096
|
|
Partial AUCs
AUC6-9
|
5644.67 hr*pg/mL
Interval 5176.704 to 6154.948
|
5624.50 hr*pg/mL
Interval 5149.945 to 6142.78
|
1.00 hr*pg/mL
Interval 0.909 to 1.093
|
49159.01 hr*pg/mL
Interval 45116.976 to 53563.164
|
53313.02 hr*pg/mL
Interval 48889.077 to 58137.277
|
1.08 hr*pg/mL
Interval 0.991 to 1.187
|
|
Partial AUCs
AUC9-12
|
2769.68 hr*pg/mL
Interval 2498.675 to 3070.079
|
3638.05 hr*pg/mL
Interval 3277.387 to 4038.399
|
1.31 hr*pg/mL
Interval 1.198 to 1.44
|
25193.87 hr*pg/mL
Interval 22743.535 to 27908.203
|
34316.26 hr*pg/mL
Interval 30955.023 to 38042.466
|
1.36 hr*pg/mL
Interval 1.245 to 1.49
|
|
Partial AUCs
AUC12-16
|
1643.22 hr*pg/mL
Interval 1458.189 to 1851.741
|
3092.55 hr*pg/mL
Interval 2739.223 to 3491.455
|
1.88 hr*pg/mL
Interval 1.679 to 2.109
|
15739.33 hr*pg/mL
Interval 13978.89 to 17721.462
|
26183.15 hr*pg/mL
Interval 23231.791 to 29509.457
|
1.66 hr*pg/mL
Interval 1.488 to 1.86
|
SECONDARY outcome
Timeframe: Hours 0 to 28Population: PK Completer Population
Rate at which a drug is removed from the system
Outcome measures
| Measure |
Treatment A
n=41 Participants
Focalin XR 5 mg capsule
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment B
n=39 Participants
CTx-1301 6.25 mg tablet
Dexmethylphenidate 6.25 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
Treatment B/A
n=43 Participants
PK Comparison of 6.25 mg CTx-1301 (treatment B) to 5 mg Focalin XR (treatment A)
|
Treatment C
n=42 Participants
Focalin XR 40 mg capsule
Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment D
CTx-1301 50 mg tablet
Dexmethylphenidate 50 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
Treatment D/C
PK Comparison of 50 mg CTx-1301 (treatment D) to 40 mg Focalin XR (treatment C).
|
|---|---|---|---|---|---|---|
|
K
|
0.18 (1/hr)
Standard Deviation 0.053
|
0.16 (1/hr)
Standard Deviation 0.040
|
0.17 (1/hr)
Standard Deviation 0.035
|
0.16 (1/hr)
Standard Deviation 0.034
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0 to 28Time (Hours) it takes for the concentration of the drug in plasma to be reduced by 50%
Outcome measures
| Measure |
Treatment A
n=41 Participants
Focalin XR 5 mg capsule
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment B
n=39 Participants
CTx-1301 6.25 mg tablet
Dexmethylphenidate 6.25 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
Treatment B/A
n=43 Participants
PK Comparison of 6.25 mg CTx-1301 (treatment B) to 5 mg Focalin XR (treatment A)
|
Treatment C
n=42 Participants
Focalin XR 40 mg capsule
Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment D
CTx-1301 50 mg tablet
Dexmethylphenidate 50 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
Treatment D/C
PK Comparison of 50 mg CTx-1301 (treatment D) to 40 mg Focalin XR (treatment C).
|
|---|---|---|---|---|---|---|
|
Half-life
|
3.77 hr*pg/mL
Standard Deviation 1.066
|
4.32 hr*pg/mL
Standard Deviation 1.866
|
4.05 hr*pg/mL
Standard Deviation 0.977
|
4.21 hr*pg/mL
Standard Deviation 1.163
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0 to 28Time (Hours) after administration of a drug when the maximum plasma concentration is reached
Outcome measures
| Measure |
Treatment A
n=41 Participants
Focalin XR 5 mg capsule
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment B
n=39 Participants
CTx-1301 6.25 mg tablet
Dexmethylphenidate 6.25 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
Treatment B/A
n=43 Participants
PK Comparison of 6.25 mg CTx-1301 (treatment B) to 5 mg Focalin XR (treatment A)
|
Treatment C
n=42 Participants
Focalin XR 40 mg capsule
Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment D
CTx-1301 50 mg tablet
Dexmethylphenidate 50 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
Treatment D/C
PK Comparison of 50 mg CTx-1301 (treatment D) to 40 mg Focalin XR (treatment C).
|
|---|---|---|---|---|---|---|
|
Tmax
|
5.00 hr*pg/mL
Interval 1.0 to 7.0
|
5.00 hr*pg/mL
Interval 1.0 to 7.0
|
6.00 hr*pg/mL
Interval 1.0 to 8.0
|
5.00 hr*pg/mL
Interval 1.0 to 10.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0 to 28Population: PK Completer Population
Delay (hours) between the time of dosing and time of appearance of concentration in the sampling
Outcome measures
| Measure |
Treatment A
n=41 Participants
Focalin XR 5 mg capsule
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment B
n=39 Participants
CTx-1301 6.25 mg tablet
Dexmethylphenidate 6.25 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
Treatment B/A
n=43 Participants
PK Comparison of 6.25 mg CTx-1301 (treatment B) to 5 mg Focalin XR (treatment A)
|
Treatment C
n=42 Participants
Focalin XR 40 mg capsule
Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment D
CTx-1301 50 mg tablet
Dexmethylphenidate 50 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
Treatment D/C
PK Comparison of 50 mg CTx-1301 (treatment D) to 40 mg Focalin XR (treatment C).
|
|---|---|---|---|---|---|---|
|
Tlag
|
0.00 hr
Interval 0.0 to 0.5
|
0.00 hr
Interval 0.0 to 0.5
|
0.00 hr
Interval 0.0 to 0.5
|
0.00 hr
Interval 0.0 to 0.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 10Population: Safety Population
TEAEs will be measured from Day 0 to Day 10 (End of Study)
Outcome measures
| Measure |
Treatment A
n=41 Participants
Focalin XR 5 mg capsule
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment B
n=39 Participants
CTx-1301 6.25 mg tablet
Dexmethylphenidate 6.25 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
Treatment B/A
n=43 Participants
PK Comparison of 6.25 mg CTx-1301 (treatment B) to 5 mg Focalin XR (treatment A)
|
Treatment C
n=42 Participants
Focalin XR 40 mg capsule
Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment D
CTx-1301 50 mg tablet
Dexmethylphenidate 50 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
Treatment D/C
PK Comparison of 50 mg CTx-1301 (treatment D) to 40 mg Focalin XR (treatment C).
|
|---|---|---|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events
|
7 participants
|
4 participants
|
22 participants
|
14 participants
|
—
|
—
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Treatment B
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment C
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Treatment D
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A
n=41 participants at risk
Focalin XR 5 mg capsule
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment B
n=39 participants at risk
CTx-1301 6.25 mg tablet
Dexmethylphenidate 6.25 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
Treatment C
n=43 participants at risk
Focalin XR 40 mg capsule
Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation
|
Treatment D
n=42 participants at risk
CTx-1301 50 mg tablet
Dexmethylphenidate 50 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
2.4%
1/41 • Number of events 1 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
4.7%
2/43 • Number of events 2 • Day -4 to Day 10
|
0.00%
0/42 • Day -4 to Day 10
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/41 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
9.3%
4/43 • Number of events 4 • Day -4 to Day 10
|
7.1%
3/42 • Number of events 3 • Day -4 to Day 10
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/41 • Number of events 1 • Day -4 to Day 10
|
2.6%
1/39 • Number of events 1 • Day -4 to Day 10
|
2.3%
1/43 • Number of events 1 • Day -4 to Day 10
|
4.8%
2/42 • Number of events 2 • Day -4 to Day 10
|
|
Eye disorders
Eye Pain
|
0.00%
0/41 • Day -4 to Day 10
|
2.6%
1/39 • Number of events 1 • Day -4 to Day 10
|
0.00%
0/43 • Day -4 to Day 10
|
0.00%
0/42 • Day -4 to Day 10
|
|
Nervous system disorders
Headache
|
0.00%
0/41 • Day -4 to Day 10
|
2.6%
1/39 • Number of events 1 • Day -4 to Day 10
|
7.0%
3/43 • Number of events 3 • Day -4 to Day 10
|
4.8%
2/42 • Number of events 2 • Day -4 to Day 10
|
|
Psychiatric disorders
Euphoric mood
|
2.4%
1/41 • Number of events 1 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
4.7%
2/43 • Number of events 2 • Day -4 to Day 10
|
2.4%
1/42 • Number of events 1 • Day -4 to Day 10
|
|
Gastrointestinal disorders
Constipation
|
2.4%
1/41 • Number of events 1 • Day -4 to Day 10
|
2.6%
1/39 • Number of events 1 • Day -4 to Day 10
|
0.00%
0/43 • Day -4 to Day 10
|
2.4%
1/42 • Number of events 1 • Day -4 to Day 10
|
|
General disorders
Feeling Abnormal
|
2.4%
1/41 • Number of events 1 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
0.00%
0/43 • Day -4 to Day 10
|
0.00%
0/42 • Day -4 to Day 10
|
|
General disorders
Pre-Existing Condition Improved
|
2.4%
1/41 • Number of events 1 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
2.3%
1/43 • Number of events 1 • Day -4 to Day 10
|
2.4%
1/42 • Number of events 1 • Day -4 to Day 10
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/41 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
2.3%
1/43 • Number of events 1 • Day -4 to Day 10
|
0.00%
0/42 • Day -4 to Day 10
|
|
Investigations
Blood Pressure diastolic increased
|
2.4%
1/41 • Number of events 1 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
0.00%
0/43 • Day -4 to Day 10
|
0.00%
0/42 • Day -4 to Day 10
|
|
Investigations
Heart Rate Increased
|
0.00%
0/41 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
2.3%
1/43 • Number of events 1 • Day -4 to Day 10
|
0.00%
0/42 • Day -4 to Day 10
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/41 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
2.3%
1/43 • Day -4 to Day 10
|
4.8%
2/42 • Day -4 to Day 10
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
0.00%
0/41 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
0.00%
0/43 • Day -4 to Day 10
|
2.4%
1/42 • Number of events 1 • Day -4 to Day 10
|
|
Nervous system disorders
Akathisia
|
0.00%
0/41 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
0.00%
0/43 • Day -4 to Day 10
|
2.4%
1/42 • Number of events 1 • Day -4 to Day 10
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/41 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
2.3%
1/43 • Number of events 1 • Day -4 to Day 10
|
0.00%
0/42 • Day -4 to Day 10
|
|
Nervous system disorders
Dizziness
|
0.00%
0/41 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
0.00%
0/43 • Day -4 to Day 10
|
4.8%
2/42 • Number of events 2 • Day -4 to Day 10
|
|
Nervous system disorders
Somnolence
|
2.4%
1/41 • Number of events 1 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
2.3%
1/43 • Number of events 1 • Day -4 to Day 10
|
0.00%
0/42 • Day -4 to Day 10
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/41 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
2.3%
1/43 • Number of events 1 • Day -4 to Day 10
|
4.8%
2/42 • Number of events 2 • Day -4 to Day 10
|
|
Psychiatric disorders
Change in Sustained Attention
|
0.00%
0/41 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
2.3%
1/43 • Number of events 1 • Day -4 to Day 10
|
2.4%
1/42 • Number of events 1 • Day -4 to Day 10
|
|
Psychiatric disorders
Frustration tolerance decreased
|
0.00%
0/41 • Day -4 to Day 10
|
2.6%
1/39 • Number of events 1 • Day -4 to Day 10
|
0.00%
0/43 • Day -4 to Day 10
|
0.00%
0/42 • Day -4 to Day 10
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/41 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
0.00%
0/43 • Day -4 to Day 10
|
4.8%
2/42 • Number of events 2 • Day -4 to Day 10
|
|
Psychiatric disorders
Irritability
|
0.00%
0/41 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
0.00%
0/43 • Day -4 to Day 10
|
4.8%
2/42 • Number of events 2 • Day -4 to Day 10
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/41 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
2.3%
1/43 • Number of events 1 • Day -4 to Day 10
|
0.00%
0/42 • Day -4 to Day 10
|
|
Vascular disorders
Hot Flush
|
2.4%
1/41 • Number of events 1 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
0.00%
0/43 • Day -4 to Day 10
|
0.00%
0/42 • Day -4 to Day 10
|
|
Vascular disorders
Phlebitis
|
2.4%
1/41 • Number of events 1 • Day -4 to Day 10
|
0.00%
0/39 • Day -4 to Day 10
|
0.00%
0/43 • Day -4 to Day 10
|
0.00%
0/42 • Day -4 to Day 10
|
Additional Information
VP of Clinical Operations and Regulatory Affairs
Cingulate Therapeutics
Phone: 913-942-2304
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institution/PI shall not have the right to use the results pertaining to Institution's/PI's activities for their own instructional or research publication objectives, unless provided written permission by Sponsor. Publication must not disclose Confidential Information. Institution and PI shall submit in writing to Sponsor review of any Publication. Sponsor shall advise Institution of information which is Confidential Information or which may impair Sponsor's ability to obtain patent protection.
- Publication restrictions are in place
Restriction type: OTHER